breast cancer
Conditions
Interventions
To evaluate the efficacy and safety of preoperative administration of Tri-weekly Docetaxel plus Cyclophosphamide plus Trastuzumab of 4 cycles in patients with HER2 positive operable breast cancer.
Sponsors
Kyoto Prefectural University of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female primary breast cancer patients who are diagnosed as HER2 positive invasive breast cancer by needle biopsy or tissue biopsy. Resectable primary breast cancer (T1c-3 N0-1 M0) and tumor size is 7 cm or smaller. 2)Age between 20 to 70 years old 3)ECOG performance status (PS): 0-1 4)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy. 5)Results from a laboratory test meet the following: a)Leukocyte count is >=3000/mm3 or b)Neutrophil count is >=2000/mm3 c)Hemoglobin >=9.0g/dL d)Platelet >=100 000/mm3 e)AST and ALT <=x 2.0 of upper limit of normal (ULN) f)Bilirubin (total bilirubin or direct bilirubin) <=1.5 of ULN g)Serum creatinine <=x 1.5 of ULN h)Baseline left ventricular ejection fraction (LVEF) is >=60% measured by echocardiography or MUGA scan. 6)Signed written informed consent
Exclusion criteria
Exclusion criteria: 1)Poorly controlled complication (malignant hypertension, myocardial infarction , congestive heart failure, bleeding). 2)Multiple primary cancer 3)Synchronous bilateral breast cancer 4)Interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan. 5)Women who are pregnant, lactating or with childbearing potential 6)Hypersensitivity to any agents necessary in the planned treatment. 7)Serious peripheral neuropathy or serious edema 8)Pleural effusion or cardiac effusion which requires treatment 9)Complication which requires prior treatment with corticosteroid 10)Suspected infection 11)Ineligible based on decision of an investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Safety,adverse events (2)Overall response rate (3)Breast conserving rate | — |
Countries
Japan
Contacts
Public ContactKatsuhiko Nakatsukasa
Kyoto Prefectural University of Medicine Endocrine & Breast Surgery
Outcome results
None listed